Determination kit for lipoprotein C3 (immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- Reagent 1: 45mL×1 Reagent 2: 15mL×1; Reagent 1: 60mL×1 Reagent 2: 20mL×1; Reagent 1: 60mL×4 Reagent 2: 20mL×4; Reagent 1: 60mL×2 Reagent 2: 20mL×2; Reagent 1: 45mL×4 Reagent 2: 15mL×4 300 test/box (Reagent 1: 57ml×1, Reagent 2: 19ml×1) 340 test/cassette (Reagent 1: 63ml×1, Reagent 2: 21ml×1) Calibrator: 1mL×1 (optional) Control: 1mL×2 (optional)试剂1:45mL×1 试剂2:15mL×1 ;试剂1:60mL×1 试剂2:20mL×1；试剂1:60mL×4 试剂2:20mL×4；试剂1:60mL×2 试剂2:20mL×2；试剂1:45mL×4 试剂2:15mL×4 300测试/盒（试剂1:57ml×1、试剂2:19ml×1） 340测试/盒（试剂1:63ml×1、试剂2:21ml×1） 校准品：1mL×1（选配） 质控品：1mL×2（选配）
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20212400369
- Approval date
- November 08, 2021
- Expiry date
- November 07, 2026
- Name
- Anhui Century Kangda Biotechnology Co., Ltd.安徽世纪康大生物科技有限公司
- Province/Region
- Anhui安徽
- Address
- Room 401, 5# Electronic Workshop, Science and Technology Innovation Center, No. 82 Huashan Road, Yingzhou Development Zone, Yingzhou District, Fuyang City阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
- Production address
- 阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
It is suitable for the quantitative determination of apolipoprotein C3 content in human serum in vitro.
适用于体外定量测定人血清中载脂蛋白C3的含量。
R1 Trimethylolaminomethane buffer 10 mmol/L Sodium chloride 0.15mol/L Polyethylene glycol 5.0% R2 Trimethylolaminomethane buffer 10 mmol/L Sheep anti-human apolipoprotein C3 antibody 65% The calibrator is lyophilized powder (optional) consisting of apolipoprotein C3 and bovine serum albumin. The low value of the control (optional), the high value of the control (optional) is lyophilized powder made of apolipoprotein C3 and bovine serum Albumin composition.
R1 三羟甲基氨基甲烷缓冲液 10mmol/L 氯化钠 0.15mol/L 聚乙二醇 5.0% R2 三羟甲基氨基甲烷缓冲液 10 mmol/L 羊抗人载脂蛋白 C3 抗体 65% 校准品为冻干粉（选配）由载脂蛋白 C3、牛血清白蛋白组成。 质控品低值（选配）、质控品高值（选配）为冻干粉由载脂蛋白 C3、牛血清 白蛋白组成。
Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months. The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days. Unopened calibrators, unopened calibrators, and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and the validity period is 12 months. After reconstitution of calibrators and quality control products, they are stored at 2 °C ~ 8 °C in the dark and stable for 5 days.
未开启的试剂应在2℃～8℃避光保存，有效期为12个月。 开启的试剂在2℃～8℃避光保存，稳定28天。 未开启的校准品、未开启的校准品、质控品在2℃～8℃密封避光保存，有效期为12个月。 校准品、质控品复溶后在2℃～8℃避光保存，稳定5天。
Access comprehensive regulatory information for Determination kit for lipoprotein C3 (immunoturbidimetric method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20212400369 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 08, 2021.
This page provides complete registration details including registrant information, province location (Anhui), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.